Verapamil is a drug which has been used in the US since 1982 for high blood pressure, migraines, and heart problems. It also lowers levels of a protein called TXNIP. The researchers running this trial believe this is important because they believe TXNIP kills beta cells as part of the onset of type-1 diabetes. So giving Verapamil should lower TXNIP which should improve beta cell survival, and stop type-1 diabetes. In addition TXNIP is known to lower inflammation, and that might have an effect on type-1 diabetes as well. TXNIP worked in mice trials.

The news here is that they have completed enrollment. There is good and bad news in that. The good news is we now know that the trial will finish in 2019, since they completed enrollment in Jan 2018 and need to gather data for a year. The bad news is that they only recruited 32 people; they were hoping for 52.

Vitamin D has been a hot topic for the last few years, and there are several different clinical trials looking at it in three different contexts: Does low Vitamin D help trigger type-1? Does increasing Vitamin D help prevent type-1? And, does increasing Vitamin D to people who have type-1, help treat or cure it? All together, there are 15 completed trials, 6 recruiting, and 2 underway but not recruiting, and one not yet started. That is strong interest.

This trial was a phase-I, honeymoon trial of 36 people. Half got Vitamin D, and half got a placebo. The patients who got Vitamin D did do a little better (used less insulin during their honeymoon), but the effect was not statistically significant.

Diamyd has been tested for over 10 years. All previous trials (which have completed) have been unsuccessful. There are currently two other Diamyd and Vitamin D trials underway. While I'm always hopeful that these tests will be successful, Diamyd's long history without success does not give me much to hope for with this trial.

How well can you predict the outcome of clinical trials? Not as well as you may think.

One of the guiding quotes of this blog is "Opinions are not important; but what is important is the reasoning behind them, the data and information they are built on, etc. In short: why a person has opinions is more important than the opinions themselves. And that includes my opinions. Especially "my opinions." This is a news article on researcher's ability to predict the outcome of studies in their field. I thought it was interesting reading:https://www.statnews.com/2018/01/22/clinical-trials-forecasting-outcomes/

Joshua Levyhttp://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot comAll the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.

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